FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters
K Number: K231015
·
Decision Jul 1, 2024
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
48
Review Days
448
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Basic Information
- Device Name
- Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters
- K Number
- K231015
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innovative Health, LLC
- Date Received
- April 10, 2023
- Decision Date
- July 1, 2024
- Product Code
- NLI
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NLI | Catheter, Angiography, Reprocessed | FDA class 2 | Cardiovascular |
Other Clearances by Innovative Health, LLC
| K Number | Device Name | ||
|---|---|---|---|
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| K212165 | Reprocessed Carto Vizigo Bi-Directional Guiding Sheath | Mar 10, 2022 | Substantially Equivalent |
| K212776 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled | Dec 20, 2021 | Substantially Equivalent |
| K211662 | Reprocessed IntellaMap Orion High Resolution Mapping Catheter | Nov 18, 2021 | Substantially Equivalent |
| K211276 | Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters | Sep 15, 2021 | Substantially Equivalent |
| K203655 | Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) | May 4, 2021 | Substantially Equivalent |